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Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00957385
First received: August 11, 2009
Last updated: June 29, 2010
Last verified: August 2009
History of Changes

August 11, 2009
June 29, 2010
June 2008
February 2011   (final data collection date for primary outcome measure)
To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting [ Time Frame: The 1st interim analysis will be done once all subjects have completed 12 cycles, and the 2nd interim analysis will be done once all subjects have completed treatment. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00957385 on ClinicalTrials.gov Archive Site
To determine the toxicity of Revlimid when given in the maintenance setting. [ Time Frame: The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients
A Randomized Phase II Study of Lenalidomide Maintenance Therapy in AML Patients Aged > 60 Years in CR1 or Higher and < 60 Years in CR2 or Higher

The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.

At present, the majority of AML patients >60 years of age that achieve CR and thereafter successfully complete further chemotherapy, are not candidates for allogeneic bone marrow transplantation (alloBMT) due to their age. Rather, this group of patients is simply observed until relapse occurs. In this age group, the median duration of CR is only ~10 months. The survival of patients <60 years of age who are not candidates for transplantation (due to donor unavailability), and who are in CR2 or higher is also extremely poor. Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
Drug: Revlimid
10mgs PO daily for 21 days of each 28 day cycle. Number of cycles: total of 24 or until subject relapses or unacceptable toxicity develops.
Other Name: Lenalidomide
  • Active Comparator: A
    Arm A will receive Revlimid.
    Intervention: Drug: Revlimid
  • No Intervention: B
    Arm B will not receive Revlimid but an observational arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
February 2012
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Acute myeloid leukemia in remission.
  • Able to take aspirin 81mgs daily.

Exclusion Criteria:

  • Pregnant or breast feeding females.
  • Known hypersensitivity to thalidomide.
  • Any prior use of lenalidomide.
Both
18 Years and older
No
Contact: Andre Schuh, MD FRCP(C) 416 946 2399 andre.schuh@uhn.on.ca
Canada
 
NCT00957385
RV-AML-PI-166
Yes
Dr Andre Schuh, University Health Network, Toronto
University Health Network, Toronto
Celgene Corporation
Principal Investigator: Andre Schuh, MD.FRCP(C) University Health Network Princess Margaret Hospital
University Health Network, Toronto
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP